Guidant clarifies defibrillator recall

Things keep going from bad to worse for limping medical device maker Guidant. This morning the company said it is rethinking its original advice to doctors treating patients who have its VENTAK PRIZM and VITALITY AVT defibrillator models. Guidant now says a programming change it had recommended to solve a glitch with the units can lead to problems in its own right. On Thursday, the company reported second-quarter profits down 15 percent, largely as a result of its recent defibrillator problems.

Meanwhile, Senate Finance Committee Chairman Chuck Grassley (R-Iowa) is interested in looking at specifics on how the company has handled the recall process itself. Grassley sent the FDA a letter yesterday demanding access to the company's post-approval reports.

- see this story [1] from the AP
- see this story [2] on Grassley's intervention
- see Guidant's information page [3]